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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Guangzhou First People's Hospital | OTHER |
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This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period followed by three treatment periods of 21-days each performed in patients with COPD. Patients will be randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg and placebo).
Patients with COPD who meet the inclusion criteria will enter the 7-days washout baseline period. After the baseline period, patients will be randomly assigned to one of the following treatment sequences:
During the treatment period patients will record their adverse events and use of rescue medication (Ipratropium bromide) in a diary. At each visit, pulmonary function tests will be performed. At V2, V4 and V6, forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) are measured at following times: immediately before tablet treatment, and at 0.5, 1, 2, 3, 4, 6, 9, 12hrs after administration of tablets, FEV1 and FVC area under curve (AUC) 0~12 hours will be analyzed. At V1, V3, V5 and V7, and FVC are measured a time in the morning. Peak expiratory flow rate (PEFR) is measured by Mini-Wright peak flow meter in the morning before treatments. All other data will be evaluated as safety status, and monitoring of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequence I | Experimental | 10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days) |
|
| sequence II | Experimental | bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) |
|
| sequence III | Experimental | placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bambuterol | Drug | Patients will be randomized allocated to receive three treatment sequences I, II and III, every treatment period is separated by a washout period of 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change in FEV1(L) and FVC(L) | The primary endpoints will be the difference in FEV1 as well as FVC between pre-treatment and post-treatment at respective treatment period (ie. Visit 2(0 week) and Visit 3(3 week), Visit 4 (4 week)and Visit 5(7 week), Visit 6 (8 week) and Visit 7(11 week)) . | pre- and post-treatment during 0 to 3 week, 4 to 7 week and 8 to 11 week |
| Measure | Description | Time Frame |
|---|---|---|
| difference of AUC(0-12h) FEV1(L) as well as AUC(0-12h) FVC(L) among 3 dose groups |
| at 0, 4, 8 week |
| change of PEFR(L/min) |
| Measure | Description | Time Frame |
|---|---|---|
| use of rescue medication | •difference of use of rescue medication (Ipratropium bromide) during the treatment period among 3 dose groups | during 0 to 3week,4 to 7 week and 8 to 11 week |
| The Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinping Zheng, MD | Guagnzhou Institute of Respiratory Disease, First affiliated hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First Municipal People's Hospital | Guangzhou | Guangdong | 510000 | China | ||
| Nanfang Hospital of Southern Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9033440 | Background | McDonald CF, Pierce RJ, Thompson PJ, Allen D, Bowler S, Breslin AB, Bowes G, Saunders N, Murree-Allen K, Frith P, Musk AW. Comparison of oral bambuterol and terbutaline in elderly patients with chronic reversible airflow obstruction. J Asthma. 1997;34(1):53-9. doi: 10.3109/02770909709071203. | |
| 10027655 | Background |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C047766 | bambuterol |
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|
| Placebo | Drug |
|
difference of Peak flow rate (PEFR) during the treatment period among 3 dose groups
| during 0 to 3 week, 4 to 7 week and 8 to 11 week |
The Baseline Dyspnea Index (BDI) will be collected before each treatment period, ie. at visits of 2, 4, 6.
Transition Dyspnoea Index (TDI) will be collected at the end of each treatment period, ie. at visits of 3, 5, 7.
| BDI at 0, 4 and 8 week, TDI at 3, 7 and 11 week |
| Tremor, Palpitation | Difference of frequency and severity of tremor, palpitation and other adverse events among 3 dose groups will be collected and analyzed during the whole study period. | up to 11 weeks |
| electrocardiogram (ECG) | Electrocardiogram (ECG) will be assessed at all visits | at -1,0,3,4,7,8,11 week |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Guangzhou Institution of Respiratory Disease (GIRD), The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Cazzola M, Calderaro F, Califano C, Di Pema F, Vinciguerra A, Donner CF, Matera MG. Oral bambuterol compared to inhaled salmeterol in patients with partially reversible chronic obstructive pulmonary disease. Eur J Clin Pharmacol. 1999 Jan;54(11):829-33. doi: 10.1007/s002280050561. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |